Mobile Observation Of Depression (MOOD)

The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Major Depressive Disorder; Major Depressive Episode
• Intervention / Treatment: Device: OCOsense

Detailed Description

Assessment of participants living with a DSM5 research diagnosis of Bipolar disorder or Major depressive disorder as well as healthy controls who will be recruited and characterised through precision phenotyping involving cross-sectional assessment of biobehavioural and physiological markers of the symptoms of depression. Correlations between objective (i.e., OCOsense glasses captured) and subjective (i.e., self-reported) symptoms of depression will be measured within as well as across diagnoses. The resulting biobehavioral clusters will form the building block of a digital phenotyping tool based upon the wider spectrum of non-verbal behaviours and physiology defined and affected by the phenotype of depression.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN1 9SB
      • Emteq Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Convenience sampling of young adults.

Description

Inclusion Criteria:

All participants:

• Ability to read & understand English. This is because the majority of our questionnaires are validated in the English language only.
• Able to walk, sit, lay and stand unaided

Clinical cases:

● ≥ 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression)

Exclusion Criteria:

Healthy control participants:

• Self-reported current or past history (suspected or diagnosed) of any psychiatric condition
• <5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)
• <5 on the PhQ-9 (no depression)
• Receiving medication for any psychiatric disorder (excluding fibromyalgia)

All participants:

• < 18 years of age or >40 years of age
• Anatomical constraints that affect fit (e.g. facial disfigurement)
• Facial nerve damage which limits the ability to make facial expressions
• Body Mass Index (BMI) >29.9 which we deem may affect physical mobility

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinical Cases; Participants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities.	Device: OCOsense; Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks
Control Cases; Participants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities.	Device: OCOsense; Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure	Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By comparing the ratio of corrugator to zygomatic muscle activation, the OCOsense glasses will produce: - Objective valence at a given time (ratio/intensity of corrugator to zygomatic muscle activation at that time).	4 hours
The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure	Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By measuring corrugator and zygomatic muscle activation, the OCOsense glasses will produce: - Objective mood during negatively valenced exposures, neutrally valenced exposures and positively valenced exposures described in terms of expression intensity and variability for each exposure.	4 hours
Identifying physical activity engagement.	The OCOsense glasses contain Inertial Measurement Units (IMU) sensors. By detecting inertial displacement over time OCOsense will detect: - Movement: a measure of movement over a period of time - specifically, how much of the time period is spent (i) stationary, (ii) in motion, (iii) fidgeting, (iv) engaging with a variety of activities of daily living	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigating the relationship between vocal prosody and self-reported subjective mood	The OCOsense glasses contain a microphone. By detecting vocal parameters over time OCOsense will detect: - the nonsemantic lexical features of speech related to pitch and tone whilst participants verbally recall a positive event in their life or engage with a semi-structured diagnostic interview.	2 hours

Collaborators and Investigators

• Sponsor: Emteq Ltd
• Investigators: Study Director: Charles Nduka, MA, MD, FRCS, Emteq CSO

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Emotion; Wearables; Multimodal; Digital phenotyping; OCOSense
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Bipolar and Related Disorders; Depressive Disorder; Disease; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MOOD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Where possible, fully anonymised data will be hosted on a secure data responsibility. Specific details will be updated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No